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临床试验/NCT03528668
NCT03528668已完成不适用

Patient Receptiveness to Using Virtual Reality as a Distractor From Pain

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2018年4月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
89
试验地点
1
主要终点
Change in Pain

研究概览

简要总结

This study will evaluate the acceptability, use, and general effect that exposure to virtual reality has on hospitalized patients reporting at least one discomfort including recent or current moderate-severe pain.

详细描述

Patients with moderate-severe pain will be approached with approval of nursing staff and front line nurse manager who determine their appropriateness for a trial of virtual reality (VR) exposure for up to 30 minutes. The trial and use of VR will be explained after meeting the inclusion criteria and they will be asked about their level of interest in trying the VR headset. If interested, the subject will indicate their verbal consent to proceed with the VR trial. They will be asked about any baseline discomforts of pain, anxiety/stress or other discomfort; which will be rated on a 0-10 numeric (visual analog) scale. A baseline heart rate will be recorded in beats per minute. The headset will be applied and adjusted for comfort, then the app will be started along with a timer to track the duration of their use up to a maximum of 30 minutes. When the Headset is removed, the duration of use will be noted. The change in post-exposure heart rate (in beats per minute) and discomforts of pain, anxiety/stress or other discomforts (subtracting baseline from 5 minute post-exposure data) will be recorded. Subjects will be asked about the ease of use, whether or not they would use VR again, and for any other comments they would like to express. The headset will be disinfected between patient use.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • English-speaking
  • Inpatients on a general care unit
  • Current or recorded moderate to severe pain in past 24 hours

排除标准

  • Receiving palliative/end of life care;
  • Admitted for treatment of psychiatric or mental health disorder
  • History of seizure or stroke
  • Legally blind or deaf
  • Moderate or severe cognitive impairment
  • Head wounds or bandages
  • On isolation precautions.

结局指标

主要结局

Change in Pain

时间窗: Change between baseline and 5 minutes after intervention

Change in subjective report of pain measured on a visual analog scale

次要结局

  • Change in Heart Rate(Change between baseline and 5 minutes after intervention)
  • Change in Anxiety(Change between baseline and 5 minutes after intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Paul Arnstein

Clinical Nurse Specialist

Massachusetts General Hospital

研究点 (1)

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